Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0185139377
Study information
Scientific title
Effect of stopping proton pump inhibitors (PPI) on the incidence of Clostridium difficile diarrhoea (CDD)
Acronym
Study hypothesis
To determine whether restricting unnecessary use of PPIs reduces the incidence of Clostridium difficile diarrhoea in hospital inpatients
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Digestive System: Diarrhoea
Intervention
Randomised controlled intervention study to determine whether restriction of PPI use to National Institute for Clinical Excellence (NICE) approved indications has an effect on subsequent incidence of Clostridium difficile diarrhoea (CDD). Interventions compared are stopping PPIs versus non stopping PPIs.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Incidence of CDD
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/03/2004
Overall trial end date
28/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
400 patients aged 65 or over admitted to hospital via Medical Assessment Unit (MAU) who are taking PPIs.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
11/03/2004
Recruitment end date
28/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Plymouth Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary